PlainRecalls

2018 Recalls

7,717 recalls · Page 88 of 155

2018 Recall Year Insight

Federal agencies issued 7,717 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 9.19% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 21.1 recalls per day across the FDA, CPSC, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 155 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2018.

On this page of 50 records, severity classification shows 1 critical, 49 moderate, and 0 lower-severity recalls. The page references 19 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ — an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2018 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number — always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate May 23, 2018

SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 23, 2018

RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.

Richard Wolf GmbH

FDA Devices Moderate May 23, 2018

DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with …

Rockwell Medical, Inc

FDA Devices Moderate May 23, 2018

BOX VMIN ZESTAW DO VATS PODSTAWOWY Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-stagge…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004

Kelyniam Global, Inc.

FDA Devices Moderate May 23, 2018

SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 23, 2018

Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radi…

Visaris DOO

FDA Devices Moderate May 23, 2018

Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.

Zimmer Biomet, Inc.

FDA Devices Moderate May 23, 2018

5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT

Ethicon Endo-Surgery Inc

FDA Devices Moderate May 23, 2018

(1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII (Item Number: …

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-s…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

(1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BOX) (2) BOX KITDE0154 BYPASS KH NORDWEST (Item Number: KITD…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 23, 2018

BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered r…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

(1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLEEVE GASTRECTOMY BOX (4) SSLEEVE ZEST DO SLEEVE GASTREKTOMIIX1 …

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code 030457) Product Usage: The Endo GIA universal and Endo GIA …

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement fo…

Tosoh Bioscience Inc

FDA Devices Moderate May 23, 2018

Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbi…

Coltene Whaledent Inc

FDA Devices Moderate May 23, 2018

Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut…

ConvaTec, Inc

FDA Devices Moderate May 23, 2018

Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code 030452) Product Usage: The Endo GIA universal and Endo GIA …

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT

Ethicon Endo-Surgery Inc

FDA Devices Moderate May 23, 2018

Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnostic radi…

Visaris DOO

FDA Devices Moderate May 23, 2018

Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.

Zimmer Biomet, Inc.

FDA Devices Moderate May 23, 2018

Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutt…

Southmedic, Inc.

FDA Devices Critical May 23, 2018

Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynam…

Abbott

FDA Devices Moderate May 23, 2018

Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology …

Volcano Corporation

FDA Devices Moderate May 23, 2018

KIT00486R OBESIDAD D. WORWARLD 2 X1 (Item Number KIT00486R) Product Usage: The Endo GIA universal and Endo GIA universal XL staple…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of th…

Tosoh Bioscience Inc

FDA Devices Moderate May 23, 2018

Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)

Kelyniam Global, Inc.

FDA Devices Moderate May 23, 2018

Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002

Kelyniam Global, Inc.

FDA Devices Moderate May 23, 2018

Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ S…

Nipro Medical Corporation

FDA Devices Moderate May 23, 2018

Trident Endoscopic Ultrasonic Aspiration Needle (FNA)

Micro-Tech (Nanjing) Co., Ltd.

FDA Devices Moderate May 23, 2018

Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" Devices Product Usage: The Endo GIA universal and Endo GIA univers…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458) Product Usage: The Endo GIA universal and Endo GIA …

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151

CooperSurgical, Inc.

FDA Devices Moderate May 23, 2018

BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the…

Bard Peripheral Vascular Inc

FDA Devices Moderate May 23, 2018

5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT

Ethicon Endo-Surgery Inc

FDA Devices Moderate May 23, 2018

MGBX ZESTAW GB LS X1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium stap…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

(1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 (Item Number: KIT-DE-0083,KIT-DE-0083 APPENEKTOMIE KI…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the …

Bard Peripheral Vascular Inc

FDA Devices Moderate May 23, 2018

(1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX PST03403 ALTERNATIVE APPENDIX KIT (Item Number: PST03403) (…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

(1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS) (2) BOX 1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GAS…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered …

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller …

Beckman Coulter Inc.

FDA Devices Moderate May 23, 2018

BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium s…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

(1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 Item Code:KITBAR021- BARIATRIC KIT X0 (3)BOX SGGLOGX1 ZESTAW DO BARIATR…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

(1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) (2)BOX BOX1073180APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180APPE1…

COVIDIEN MEDTRONIC

FDA Devices Moderate May 23, 2018

Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiog…

Visaris DOO

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2018 with 2017 →

Data Sources

  • Source: FDA openFDA Enforcement API — calendar-year recall filings for food, drugs, and devices
  • Source: CPSC + NHTSA — consumer product and vehicle recall feeds for 2018